Details for New Drug Application (NDA): 021356

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NDA 021356 describes VIREAD, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the VIREAD profile page.

The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

Summary for 021356

Tradename:	VIREAD
Applicant:	Gilead Sciences Inc
Ingredient:	tenofovir disoproxil fumarate
Patents:	0

Pharmacology for NDA: 021356

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 021356

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356	NDA	Gilead Sciences, Inc.	61958-0401	61958-0401-1	30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0401-1)
VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356	NDA	Gilead Sciences, Inc.	61958-0404	61958-0404-1	30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0404-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Oct 26, 2001	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Jan 18, 2012	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jan 18, 2012	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021356

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012	6,043,230*PED	⤷ Subscribe
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012	6,043,230*PED	⤷ Subscribe
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001	5,935,946*PED	⤷ Subscribe
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012	5,935,946*PED	⤷ Subscribe
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001	6,057,305	⤷ Subscribe
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